Serotonergic Pharmacotherapy for Agitation of Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00009204
• Date of registration: 23/01/2001
• Prospective Registration: No
• Primary sponsor: Bruce Pollock
• Public title: Serotonergic Pharmacotherapy for Agitation of Dementia SPAD
• Scientific title: Serotonergic Pharmacotherapy for Agitation of Dementia
• Date of first enrolment: September 1995
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00009204
• Study type: Interventional
• Study design: Allocation: Randomized. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Bruce G. Pollock, M.D., Ph.D.
• Affiliation: Western Psychiatric Institute and Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meets DSM-IV criteria for diagnosis of dementia of the Alzheimer's type (AD), Vascular
dementia (VD), mixed (AD and VD) or dementia NOS (Not Otherwise Specified)

- Presents with psychosis or behavioral problems severe enough to endanger the patient's
health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one
of the Neurobehavioral Rating Scale (NBRS) agitation items (8,11,14) or psychosis
items (16,18,20) and are not secondary to physical illness nor amenable to
environmental optimization

- Able to participate in study evaluations and ingest oral medication

- Has next of kin or a guardian available to consent to patient's participation.

Exclusion Criteria:

- Has an unstable medical illness including significant cardiac (specifically
bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness
(especially Parkinson's disease) other than dementia

- Meets DSM-IV criteria for Delirium upon admission to Western Psychiatric Institute and
Clinic

- Has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks
with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic
drug washout prior to entering the protocol)

- Is currently being treated with cognitive enhancing drugs (Tacrine or Aricept) or any
experimental drug

- Has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression

- Has preexisting orthostatic hypotension (with > 20 mmHg change from sitting to
standing pressure)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dementia

Dementia, Vascular

Alzheimer Disease

Intervention(s)

Drug: Perphenazine [Trilafon]

Drug: Citalopram [Celexa]

Secondary ID(s)

DSIR GT-GP

IA0014

R01MH059666-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)